A Randomized Trial Comparing Epirubicin/Cyclophosphamide Followed by Weekly Paclitaxel Versus Epirubicin/Paclitaxel Followed by Weekly Paclitaxel as Adjuvant Therapy for Operable Breast Cancer Patients Less Than 40 Years Old (PAY)
This study is currently recruiting participants.
Verified December 2009 by Fudan University
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT01026116
First received: December 3, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
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Purpose
Manifold data revealed that young breast cancer patients are characterized by aggressive clinical history. The purpose of this study is to evaluate the efficacy and safety of different strategies incorporating paclitaxel to anthracycline-based regimens in young breast cancer patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: A Drug: B |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Fudan University:
Primary Outcome Measures:
- disease-free survival [ Time Frame: every one year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- overall survival [ Time Frame: every one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1664 |
| Study Start Date: | December 2009 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: A
epirubicin/cyclophosphamide followed weekly paclitaxel
Drug: B
epirubicin/paclitaxel followed by weekly paclitaxel
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Female patients, age 18~40
- Unilateral, operable, histologically confirmed adenocarcinoma of the breast
- Stage I-III
- Primary surgery with clear margins plus axillary dissection
- Able to start protocol Rx within 4 weeks of surgery
- HER-2 positive (IHC 3+ OR FISH+) and sequential use of trastuzumab followed by chemotherapy
- Occult breast cancer with histologically confirmed primary invasive carcinoma or DICS with microinvasion in the ipsilateral breast after surgery
- ECOG performance status 0-1
- Adequate cardiac, renal, hepatic and hematologic function
Exclusion Criteria:
- Metastatic disease
- Bilateral breast cancer (synchronous or metachronous)
- Prior radiation therapy, hormonal therapy and chemotherapy for breast cancer
- Previous cancer (except treated basal cell and squamous cell carcinoma of the skin or cancer of the uterine cervix)
- HER-2 positive (IHC 3+ OR FISH+) and concurrence use of adjuvant chemotherapy and trastuzumab
- Documented history of cardiac disease contradiction anthracyclines
- Concurrent serious illness
- Peripheral neuropathy of CTC grade>1
- History of hypersensitivity to drugs formulated in Cremophor EL polyoxyethylated castor oil), the vehicle used for commercial paclitaxel formulations
- Pregnancy or lactation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026116
Contacts
| Contact: Wenjin Yin | 86(21)64175590 ext 8700 | followroad@yahoo.com.cn |
Locations
| China | |
| Department of Breast Surgery, Cancer Hospital, Fudan University | Not yet recruiting |
| Shanghai, China, 200032 | |
| Contact: Wenjin Yin 86(21)64175590 ext 8700 followroad@yahoo.com.cn | |
| Principal Investigator: Zhimin Shao | |
| Department of Breast Surgery, Cancer Hospital, Fudan University | Recruiting |
| Shanghai, China, 200032 | |
| Contact: Zhimin Shao 86(21)64175590 ext 8807 zhimingshao1962@yahoo.com.cn | |
| Contact: Wenjin Yin 86(21)64175590 ext 8700 followroad@yahoo.com.cn | |
| Principal Investigator: Zhimin Shao | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Zhimin Shao | Cancer Hospital, Fudan University |
More Information
No publications provided
| Responsible Party: | Base for drug clinical trials, Cancer Hospital, Fudan University, Department of Breast Surgery, Cancer Hospital, Fudan University |
| ClinicalTrials.gov Identifier: | NCT01026116 History of Changes |
| Other Study ID Numbers: | SHBCC09007 |
| Study First Received: | December 3, 2009 |
| Last Updated: | December 3, 2009 |
| Health Authority: | China: Ethics Committee |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Cyclophosphamide Epirubicin Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013